Stryker Recalls Naera Hospital Bassinet Mattresses Due to Air Expansion Risk
Stryker is recalling Naera Hospital Bassinet mattresses because air expansion at high altitudes may create gaps, posing a risk of patients rolling over.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (patient rolling over) where the highest possible severity is death, but no injuries or illnesses have been reported.
Plain-English summary
Stryker Medical Division of Stryker Corporation is recalling 5,915 units of the Naera Hospital Bassinet, Model No. 4402. The recall involves the mattresses used in these bassinets, which were distributed nationwide and to 15 foreign countries including Argentina, Australia, Canada, and the United Kingdom.
The recall was initiated after it was identified that the volume of air inside the mattress may expand in regions of high altitude. This expansion can result in an unintended gap between the plateau of the inflated patient surface and the tub. A Health Hazard Evaluation identified the potential risk of patients moving out of position and rolling over on the mattress. While the highest possible severity of harm associated with this condition is death, there have been no reports of injury or harm to date.
Although the condition has only presented in regions of high altitude, Stryker has chosen to replace all Naera mattresses in the field. Hospitals and facilities should check their inventory for the affected serial numbers listed in the official recall notice and contact Stryker for replacement instructions.
The recalled product
- Product
- Naera Hospital Bassinet, Model No. 4402
- Manufacturer
- Stryker Medical Division of Stryker Corporation
- Affected units
- 5,915
Distribution
Distributed nationwide across the United States.
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